Skip to content

Clinical Study on Serology and Pathology of Granulomatous Mastitis of Different TCM Syndrome Types

Clinical Study on Serology and Pathology of Granulomatous Mastitis of Different TCM Syndrome Types

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2200006848
Enrollment
Unknown
Registered
2022-12-01
Start date
2022-12-05
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

granulomatous mastitis

Interventions

Post ulceration group:Puncture of breast lesions and Draw venous blood
Clinical healing group:Draw venous blood
Mass stage group:Puncture of breast lesions and Draw venous blood
Abscess stage group:Puncture of breast lesions and Draw venous blood
Health volunteer group: Draw venous blood

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion criteria of GM patients (1) Female patients who meet the diagnostic criteria of traditional Chinese and western medicine and syndromes of GM and are diagnosed as GM by pathological biopsy. (2) Women older than 18 years. (3) No other basic diseases. (4) Volunteer to participate in clinical research and sign the informed consent form. Inclusion criteria for healthy volunteers (1) Women aged>18 years, matched with the age of patients with granulomatous mastitis. (2) No other basic diseases. (3) Volunteer to participate in clinical research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: GM patient exclusion criteria (1) Patients with breast fibroma, breast cancer, breast hyperplasia and other breast tumors or breast diseases. (2) Patients with serious primary diseases, serious diseases that affect the survival of patients, or mentally and legally recognized disabled patients. (3) The patients in the clinical recovery period and the patients in the other three stages have intersected. Exclusion criteria for healthy volunteers (1) Health volunteers participating in other medical research.

Design outcomes

Primary

MeasureTime frame
Polynuclear giant cells, neutrophils, lymphocytes, plasma cells, microabscesses, granulomas;White blood cell count,Percentage of neutrophils,CRP,ESR,IL-8,IL-10,IL-22,IL-23,IL-33,PRL;TNF-a\CD68\CD163\CCL-5\IgG4 \TLR2\TLR4;Mycobacterium tuberculosis;

Secondary

MeasureTime frame
Bacterial culture of secretions;Breast ultrasound;Breast pain;

Countries

Chnia

Contacts

Public ContactYubo Guo
guoyubo1101@163.com+86 010-87907365

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026